Schering-Plough: FDA wants labels, data for Saphris

LONDON (MarketWatch) -- Schering-Plough
SGP, +5.86%
said the Food and Drug Administration has proposed labeling for Saprhis to treat both schizophrenia in adults and manic or mixed episodes associated with bipolar I disorder in adults. The FDA is also asking for more data, but Schering-Plough noted that no additional clinical trials have been requested. Schering-Plough anticipates responding in the first quarter of 2009.

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